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52 Week Trial of Liraglutide in Type 1 Diabetes (LIDO)

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ClinicalTrials.gov Identifier: NCT01787916
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Brief Summary:

To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.

Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Liraglutide Drug: Placebos Phase 4

Detailed Description:
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
Study Start Date : April 2013
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Liraglutide
Liraglutide, s.c., 1.8 mg, die, 24 weeks
Drug: Liraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Other Name: Victoza
Placebo Comparator: Placebo
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
Drug: Placebos
placebo will be compared to liraglutide for 24 weeks in a cross-over design



Primary Outcome Measures :
  1. Assessment of Changes in Glycemic Control by HbA1c. [ Time Frame: Measure changes in HbA1c at 24 and 52 weeks from baseline ]
    To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.


Secondary Outcome Measures :
  1. Assessment of Changes on Adipose Tissue [ Time Frame: Measure changes in the composite at 24 and 52 weeks from baseline ]
    To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years

Exclusion Criteria:

  • diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787916


Locations
Canada
CHU de Québec
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Novo Nordisk A/S
Investigators
Principal Investigator: Stanley John Weisnagel, MD CHU de Québec
Principal Investigator: Martin D'Amours, MD CHU de Québec

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01787916     History of Changes
Other Study ID Numbers: 2013LIDO
First Posted: February 11, 2013    Key Record Dates
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018
Last Verified: March 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual data will not be available to other researchers

Keywords provided by CHU de Quebec-Universite Laval:
type 1 diabetes
overweight
insulin
liraglutide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists